中国医学独立实验室发展现状调查报告

Nationwide Investigation and Analysis of Present Status of Independent Clinical Laboratories in China

目的：全面了解中国医学独立实验室发展现状和目前存在的问题，为探讨和提出先进高效的监管服务模式，合理配置医疗资源提供可靠的参考依据。方法由中国卫生和计划生育委员会统计信息中心协调省市卫生和计划生育委员会，对北京、上海、广州和杭州四个城市，采用书面调查和现场调研相结合的方式对以上地区的医学独立实验室进行调查分析。结果在调查的38家医学独立实验室中，注册资本最多的为4490万，最少的为200万；实验室员工最多的为1105人，最少的为19人，技术人员占45％，管理人员占55％；38所医学独立实验室中，6家通过了 ISO15189认可，4家通过了CAP认可，23家未进行任何认可；调查的实验室中，17家参与了地方省市组织的室间质量控制活动，29家参与了全国的室间质量控制活动。结论虽然我国医学独立实验室在自身控制和标准化方面已有一定的发展，但在准入管理和退出机制，卫生行政部门的监督管理机制，服务模式的规范和标准等方面有待进一步的发展和完善。

Objective To build a supervision mechanism for independent clinical labs （ICL）,surveyed the current situation of such novel institutions in China.Methods By way of the nationwide network of clinical labs,ICL in China were surveyed by written questionnaires and spot inspection.Results In the surveyed 38 ICLs,the maximum registered capital was 44 900 thousands,the minimum was 2 000 thousands.The maximum number of employee was 1 105,the minimum was 19.6 labs passed ISO15189 ratification,4 labs passed CAP ratification.17 labs participated in local external quality control,29 labs par-ticipated in national external quality control.Conclusion Although ICL in our country have developed well in the past dec-ade,such vulnerabilities as unbalanced staff ratio,full-range quality control bugs,cutthroat competition,asymmetrical infor-mation disclosure and bio-safety have loomed in the meantime.It is time to formulate a stricter industry access system and appropriate regulatory modes.